510(k) · Cleared
Recalled · 2010Advantage Sim 6.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems · KPQ System, Simulation, Radiation Therapy
Cleared on Jul 29, 2002 as substantially equivalent to K951830 (General Electric Co., 1995) after a 60-day review. Its family tree reaches back 1 generation to 1995. 1 of the 219 devices in its family, counting itself, has a Class I recall. 217 later devices descend from it. It has been recalled once.
- Decided
- Jul 29, 2002
- Review
- 60 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951830 (1995). 217 later devices descend from it, 3 citing it directly. 1 of the 219 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK951830 Advantage SimGeneral Electric Co. · 1995 · Recalled
- This deviceK021780 Advantage Sim 6.0General Electric Medical Systems · 2002
- Descendant · cites it directly · 216 of its ownK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 3 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 4 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 217 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 217 · See all- K032915Advantage 4D OptionGe Medical Systems, LLC · 2003 · cites it directly216descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 3 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 3 generations on70descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 4 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951830 | Advantage Sim | General Electric Co. | 1995 | 1 |
| 0 (this device) | K021780 | Advantage Sim 6.0 | General Electric Medical Systems | 2002 | — |
| +1 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| +2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +4 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 14 | 0 |
| 2022 | 21 | 0 |
| 2023 | 17 | 0 |
| 2024 | 19 | 0 |
| 2025 | 22 | 1 |
| 2026 | 23 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951830 | Advantage SimSummary page 1…ent to the device listed below: iModel: Advantage Sim 1.2 hlanufacturer: Genera! E!ec:ik Medical SysterA 510 (k): K95 1830 4. Device Description : Advantage Sim 6.0. is used to prepare geometric and anatomical data relating to… | 1995 |
What descends from it? (217)
See all 2173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2010 | Not classified | Z-1473-2011 | Software design | GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combination with specified other functions of… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All KPQ devicesKPQ System, Simulation, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KPQ
Too few KPQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KPQ
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPQ
1in 2020
MAUDE reports naming product code KPQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 6 | 17 |
| 2008 | 1 | — | 3 | 12 |
| 2009 | 1 | — | 1 | 7 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 1 | 11 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Advantage Sim 6.0 is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior io dosimetry plannin,o. Anatomical volumes can be defined in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical…
Read the full statement (117 words)
Advantage Sim 6.0 is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior io dosimetry plannin,o. Anatomical volumes can be defined in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and seometric treatments fields are displayed on transverse CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye‘s view display with or without the display of defined structures with or without the display of disjttaly reconstructed radiogaph.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021780: Advantage Sim 6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021780
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026